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This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD109 Dose 1 | Experimental |
| |
| AD109 Dose 2 | Experimental |
| |
| AD504 Dose 1 | Experimental |
| |
| AD504 Dose 2 | Experimental |
| |
| Atomoxetine 1 | Active Comparator |
| |
| Atomoxetine 2 | Active Comparator |
| |
| Placebo 1 | Placebo Comparator |
| |
| Placebo 2 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD109 | Drug | Oral administration at bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AHI, combined AD109 dose arms vs. combined placebo arms | Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in AHI, combined AD504 dose arms vs. combined placebo arms | Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography | 28 Days |
| Change in AHI, combined atomoxetine dose arms vs. combined placebo arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Monica Clinical Trials | Los Angeles | California | 90025 | United States | ||
| Pacific Research Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37812772 | Derived | Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J. The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2023 Dec 15;208(12):1316-1327. doi: 10.1164/rccm.202306-1036OC. |
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|
| AD504 |
| Drug |
Oral administration at bedtime |
|
| Atomoxetine Hydrochloride | Drug | Oral administration at bedtime |
|
| Placebo | Drug | Oral administration at bedtime |
|
Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
| 28 Days |
| San Diego |
| California |
| 92103 |
| United States |
| SDS Clinical Trials, Inc. | Santa Ana | California | 92705 | United States |
| Delta Waves | Colorado Springs | Colorado | 80918 | United States |
| Teradan Clinical Trials | Brandon | Florida | 33511 | United States |
| Research Centers of America -- Hollywood | Hollywood | Florida | 33024 | United States |
| Sleep Medicine Specialists of South Florida | Miami | Florida | 33176 | United States |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30328 | United States |
| Chicago Research Center | Chicago | Illinois | 60634 | United States |
| The Center for Sleep & Wake Disorders | Chevy Chase | Maryland | 20815 | United States |
| Sleep Disorders Centers of the Mid-Atlantic (SDCMA) | Glen Burnie | Maryland | 21061 | United States |
| Neurocare | Newton | Massachusetts | 02459 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48377 | United States |
| Sleep and Attention Disorders Institute | Sterling Heights | Michigan | 48314 | United States |
| Minnesota Lung Center / Minnesota Sleep Institute | Woodbury | Minnesota | 55125 | United States |
| St. Luke's Hospital Sleep Medicine | Chesterfield | Missouri | 63017 | United States |
| Clayton Sleep Institute | Maplewood | Missouri | 63143 | United States |
| Clinilabs | New York | New York | 10016 | United States |
| Coastal Carolina Health Care, P.A. | New Bern | North Carolina | 28562 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Intrepid Research | Cincinnati | Ohio | 45245 | United States |
| Brian Abaluck, LLC | Malvern | Pennsylvania | 19355 | United States |
| Bogan Sleep Consultants LLC | Columbia | South Carolina | 29201 | United States |
| Velocity Clinical Research | Greenville | South Carolina | 29615 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2026 | Jun 29, 2026 | 11 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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